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PARI GmbH's eFlow, An Electronic Aerosol Device For Medication Delivery, Receives FDA 510(k) Market Clearance


10/19/2005 5:11:24 PM

MONTEREY, Calif., May 18 /PRNewswire/ -- PARI's new electronic nebulizer, the eFlow, was cleared for market by the US Food and Drug Administration on May 5, 2004. eFlow is a small, silent, aerosol delivery device that takes liquid medications and generates a dense aerosol that can be inhaled into the lungs. The cordless eFlow was designed to fit the needs of respiratory patients, such as COPD, asthma and cystic fibrosis sufferers, because it significantly shortens typical nebulization times and improves medication delivery compared to current nebulizers. The gentle aerosol generation of eFlow has also demonstrated the potential to aerosolize suspensions and more fragile molecules including, peptides, proteins or liposomes either avoiding or reducing degradation.

(Photo: http://www.newscom.com/cgi-bin/prnh/20040518/SFTU024LOGO-ahttp://www.newscom.com/cgi-bin/prnh/20040518/SFTU024-b )

"The eFlow represents a significant advance in aerosol delivery to the lungs. Patients with CF and other chronic lung diseases are tasked with inhaling time-consuming, nebulized drugs on a daily basis. The eFlow may improve their quality of life by providing faster, silent, portable and versatile aerosol drug delivery. Companies developing new aerosol drugs now have the opportunity to reduce the time burden of therapy," says David E. Geller, M.D., Pediatric Pulmonologist at Nemours Children's Hospital in Orlando, Florida.

The eFlow represents the opportunity to match inhaled drug delivery between the nebulizer and the drug formulation. This is important with new drugs being developed for inhalation. Treatment times can be significantly reduced from 10-15 minutes with traditional nebulizers to as low as 3-5 minutes depending on the formulation and fill volumes. The eFlow provides an ideal platform for these developments: rapid drug delivery, efficiency, ideal particle sizing, low residual volume, and optimal performance matched to the inhaled drug. This is an important development for patients, clinicians, third-party payors, and healthcare regulators," says Dean Hess, Ph.D., RRT, Assistant Director Of Respiratory Care Services, Massachusetts General Hospital.

"We intend to license eFlow to interested pharmaceutical companies who want to develop a unique, optimized drug and device match," says Geoff A. Hunziker, Senior Vice-President For The PARI Aerosol Research Institute, USA. "CORUS Pharma, who recently completed a Series C Round of financing, has licensed customized eFlow products for two clinical programs including inhaled aztreonam (a monobactam antibiotic) for cystic fibrosis and inhaled lidocaine for asthma. We are currently in discussions with other pharmaceutical companies interested in eFlow," added Hunziker.

"We have been impressed by the performance and patient enthusiasm to the eFlow(R) in our clinical trials," said A. Bruce Montgomery, M.D., CEO of Corus Pharma. "PARI has been a responsive partner and their contributions have been key to our success."

"The PARI Aerosol Research Institute offers the eFlow device and comprehensive formulation expertise to optimize eFlow to specific formulations, as we did with CORUS Pharma's aztreonam project. For aztreonam, our experienced and GMP certified pharma division contributed the CMC package including the preparation of different salts, development of various formulations and the corresponding analytical methods, and finally, the match of an optimized formulation (a lyophilized aztreonam lysinate) with a customized eFlow," says Manfred Keller, Pharm. D., Ph. D., Director Pharmaceuticals and Senior Member of the PARI Executive Board.

At the core of the eFlow is a stainless steel membrane with 4,000 laser drilled holes. Laser drilling allows flexibility to customize particle size, ensure reproducibility, and maintain a high output rate with smaller particles. The perforated membrane is vibrated at high frequencies in a resonant "bending" mode which yields high particle output rates.

About PARI

The PARI Aerosol Research Institute (ARI) is a division of PARI GmbH focused on new aerosol delivery technology and pharmaceutical formulation development. ARI Core competencies include Product Development, Engineering, Aerosol Testing, Manufacturing and Formulation Development. PARI GmbH, a privately held company founded in 1906, is considered the worldwide leader in aerosol delivery via efficient nebulizer systems. PARI products are well established in clinical trials for existing and new respiratory medications for COPD, asthma and cystic fibrosis. PARI products are available in over 70 countries worldwide.

Photo: http://www.newscom.com/cgi-bin/prnh/20040518/SFTU024LOGO-ahttp://www.newscom.com/cgi-bin/prnh/20040518/SFTU024-bAP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.comPARI Aerosol Research Institute

CONTACT: Europe, Dr. J.C. Stein, +49-89-74-28-46-69, or j_stein@pari.de,or USA, Geoff Hunziker, +1-408-892-2097, or geoff.hunziker@pari.com, both of PARI Aerosol Research Institute



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